Phase 3 N=630 Treatment

Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00054717 ↗

Enrolled (actual)

630

Serious AEs

28.1%

Results posted

Nov 2009

Primary outcome: Primary: Treatment Response at Week 48 — 33.80; 16.20 percentage of participants — p=0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tipranavir (Drug); Ritonavir(r) (Drug); Comparator Protease Inhibitor (CPI) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Response at Week 48	33.8; 16.2	0.0001 sig
PRIMARY Time to Treatment Failure Through 48 Weeks of Treatment	113; 0	0.0001 sig
SECONDARY Treatment Response at Week 24	42.1; 23.6	0.0001 sig
SECONDARY Treatment Response at Week 2	53.1; 34.3	0.0001 sig
SECONDARY Treatment Response at Week 4	52.4; 33.3	0.0001 sig
SECONDARY Treatment Response at Week 8	52.4; 33.3	0.0001 sig
SECONDARY Treatment Response at Week 16	45.7; 27.5	0.0001 sig
SECONDARY Treatment Response at Week 32	37.9; 19.4	0.0001 sig
SECONDARY Treatment Response at Week 40	35.4; 17.8	0.0001 sig
SECONDARY Treatment Response at Week 48	33.8; 16.2	0.0001 sig
SECONDARY Treatment Response at Week 56	32.5; 15.9	0.0001 sig
SECONDARY Treatment Response at Week 64	31.3; 15.5	0.0001 sig
SECONDARY Treatment Response at Week 72	29.6; 14.9	0.0001 sig
SECONDARY Treatment Response at Week 80	28; 14.2	0.0001 sig
SECONDARY Treatment Response at Week 88	27.3; 12.9	0.0001 sig
SECONDARY Treatment Response at Week 96	26.7; 11.7	0.0001 sig
SECONDARY Time to Treatment Failure Through 96 Weeks of Treatment	114; 0	0.0001 sig
SECONDARY Time to Confirmed Virologic Failure Through 48 Weeks of Treatment	113; 0	0.0001 sig
SECONDARY Time to Confirmed Virologic Failure Through 96 Weeks of Treatment	116; 0	0.0001 sig
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF	79.1; 50.5	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 2	63.3; 40.1	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 4	63.3; 40.1	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 8	55.9; 34.3	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 16	47.3; 26.5	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 24	43.1; 22.3	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 32	38.9; 19.1	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 40	36.7; 17.5	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 48	36.3; 16.2	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 56	34.1; 15.5	—
SECONDARY Virologic Response (Viral Load >= 1 Log Drop) at Week 64	34.1; 16.2	—
SECONDARY Median Change From Baseline in Viral Load to Week 2	-1.36; -0.57	—
SECONDARY Median Change From Baseline in Viral Load to Week 4	-1.56; -0.46	—
SECONDARY Median Change From Baseline in Viral Load to Week 8	-1.6; -0.43	—
SECONDARY Median Change From Baseline in Viral Load to Week 16	-1.08; -0.32	—
SECONDARY Median Change From Baseline in Viral Load to Week 24	-0.81; -0.3	—
SECONDARY Median Change From Baseline in Viral Load to Week 32	-0.73; -0.24	—
SECONDARY Median Change From Baseline in Viral Load to Week 40	-0.74; -0.23	—
SECONDARY Median Change From Baseline in Viral Load to Week 48	-0.61; -0.24	—
SECONDARY Median Change From Baseline in Viral Load to Week 56	-0.57; -0.23	—
SECONDARY Median Change From Baseline in Viral Load to Week 64	-0.6; -0.23	—
SECONDARY Median Change From Baseline in Viral Load to Week 72	-0.65; -0.21	—
SECONDARY Median Change From Baseline in Viral Load to Week 80	-0.64; -0.21	—
SECONDARY Median Change From Baseline in Viral Load to Week 88	-0.64; -0.21	—
SECONDARY Median Change From Baseline in Viral Load to Week 96	-0.6; -0.21	—
SECONDARY Mean Change From Baseline to Week 2 in CD4+ Cell Count	23; 19	—
SECONDARY Mean Change From Baseline to Week 4 in CD4+ Cell Count	41; 22	—
SECONDARY Mean Change From Baseline to Week 8 in CD4+ Cell Count	49; 25	—
SECONDARY Mean Change From Baseline to Week 16 in CD4+ Cell Count	55; 30	—
SECONDARY Mean Change From Baseline to Week 24 in CD4+ Cell Count	54; 24	—
SECONDARY Mean Change From Baseline to Week 32 in CD4+ Cell Count	51; 26	—
SECONDARY Mean Change From Baseline to Week 40 in CD4+ Cell Count	50; 24	—
SECONDARY Mean Change From Baseline to Week 48 in CD4+ Cell Count	46; 28	—
SECONDARY Mean Change From Baseline to Week 56 in CD4+ Cell Count	52; 26	—
SECONDARY Mean Change From Baseline to Week 64 in CD4+ Cell Count	50; 26	—
SECONDARY Mean Change From Baseline to Week 72 in CD4+ Cell Count	50; 24	—
SECONDARY Mean Change From Baseline to Week 80 in CD4+ Cell Count	55; 26	—
SECONDARY Mean Change From Baseline to Week 88 in CD4+ Cell Count	60; 29	—
SECONDARY Mean Change From Baseline to Week 96 in CD4+ Cell Count	60; 28	—
SECONDARY Time to New CDC Class C Progression Event or Death.	448; 284	0.9894
SECONDARY Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF	53.4; 32.4	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 2	14.8; 13.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 4	28.3; 19.1	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 8	37.3; 23.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 16	35.7; 20.7	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 24	34.4; 16.5	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 32	32.8; 14.9	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 40	32.8; 14.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 48	30.5; 13.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 56	29.6; 13.9	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 64	28.6; 13.3	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 72	28.9; 12.9	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 80	27.7; 13.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 88	27.7; 12.6	—
SECONDARY Virologic Response (VL < 400 Copies/ml) at Week 96	26.7; 11.7	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF	37.9; 20.4	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 2	1.9; 1.9	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 4	6.4; 4.2	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 8	16.1; 8.1	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 16	23.5; 9.4	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 24	24.8; 10	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 32	24.8; 10	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 40	23.5; 8.4	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 48	22.5; 9.7	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 56	21.5; 10	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 64	22.8; 10.7	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 72	21.2; 11.3	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 80	20.6; 10.7	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 88	22.2; 9.7	—
SECONDARY Virologic Response (VL < 50 Copies/ml) at Week 96	20.9; 9.4	—
SECONDARY Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities	1.3; 0.7; 0; 0; 5.3; 5.3	—

Summary

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Eligibility Criteria

Inclusion Criteria

Patients meeting the following criteria will be eligible for participation in th is study:

Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:

30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.

At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.
Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

Exclusion criteria

Patients with any of the following criteria are excluded from participation in t he study:

Antiretroviral (ARV) medication naïve.
Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00054717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.